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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Occupational asthma due to piperazine citrate (Case Report)
Author:
S. Quirce, R. Pelta, J. Sastre
Year:
2006
Bibliographic source:
J Investig Allergol Clin Immunol 2006; Vol. 16(2): 138-139

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Skin sensitization study of Piperazine citrate was conducted by using Skin prick test on a 42-year-old woman.
GLP compliance:
not specified
Type of study:
other: Skin prick test
Justification for non-LLNA method:
Skin sensitization study of Piperazine citrate was conducted by using Skin prick test on a 42-year-old woman following the observed occupational effects.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Piperazine citrate - Molecular formula: C12H30N6•Cl2H16O14 - Molecular weight: 642.76 g/mole - Substance type: Organic - Physical state: Solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Piperazine citrate - Molecular formula: C12H30N6•Cl2H16O14 - Molecular weight: 642.76 g/mole - Substance type: Organic - Physical state: Solid

In vivo test system

Test animals

Species:
human
Strain:
other: not applicable
Sex:
female
Details on test animals and environmental conditions:
- Age at study initiation: 42-year-old

Study design: in vivo (non-LLNA)

Induction
Route:
other: inhalation
Vehicle:
other: air
Concentration / amount:
0 mg/ml, 10 mg/ml
Adequacy of induction:
not specified
Challenge
Adequacy of challenge:
not specified
No. of animals per dose:
0 mg/ml: 5 10 mg/ml : 1 female woman
Details on study design:
No data available
Challenge controls:
No data available
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data available

In vivo (non-LLNA)

Results
Key result
Reading:
1st reading
Group:
test group
Dose level:
10 mg/ml
No. with + reactions:
1
Total no. in group:
1
Clinical observations:
5 mm wheal
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 10 mg/ml . No with. + reactions: 1.0. Total no. in groups: 1.0. Clinical observations: 5 mm wheal.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Piperazine citrate when exposed at a concentration of 10 mg/ml to the skin of 42-yr-old woman showed 5 mm wheal and is positive for skin sensitization. Thus Piperazine citrate can be classified as skin sensitising under category 1 as per CLP classification criteria.
Executive summary:

Skin sensitization test of Piperazine citrate was conducted on a 42-year-old woman by using Skin prick test following the observed occupational effects.. A 42-yr-old woman was exposed with the test compound Piperazine citrate at a concentration of 10 mg/ml produced which produce 5 mm wheal in the patient. Since the women showed positive skin senitization reaction for Piperazine citrate, it is considered to be classified as skin sensitising under category 1 as per CLP classification criteria.